Methotrexate-Teva injection for 25mg / ml 2 ml No. 1 bottle

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Methotrexate-Teva solution for injections 25mg / ml 2 ml No. 1 bottle

Release form

injection solution

Composition

1 flacon contains methotrexate 50 mg

pharmachologic effect

Methotrexate is an antitumor agent from the group of folic acid antagonist antimetabolites. Interferes with the synthesis of purine nucleotides and thymidylate. Violates the synthesis of DNA and RNA, inhibits cell division and growth, causes their death.
It has S-phase specificity, is active against tissues with high proliferative activity of cells, inhibits the growth of malignant tumors. The most sensitive are actively dividing cells of the tumors, as well as the bone marrow, the embryo, the mucous membranes of the oral cavity, the intestines, the bladder.

Indications

trophoblastic tumors
acute leukemia (especially lymphoblastic and myeloblastic options),
neuroleukemia,
non-Hodgkin lymphomas, including lymphosarcomas,
Breast cancer, squamous cell cancer of the head and neck, lung cancer, skin cancer, cervical and vulvar cancer, esophageal cancer, kidney cancer, bladder cancer, germ cell tumors of the testicles and ovaries, penile cancer, retinoblastomy, medullloe, medulus, ophthalmolloid, ovarian cancer, medulloma of the penis, ovarian cancer of the penis, retinoblastoma
osteogenic carcinoma and carcinoma of soft tissues, Sarcoma Ewing,
severe forms of psoriasis,
mushroom mycosis (far gone stage),
rheumatoid arthritis (with the ineffectiveness of standard therapy).
Contraindications
Methotrexate has tertogenic properties and can cause death of the fetus, as a result of which it is contraindicated in pregnant women.

Methotrexate is excreted into breast milk, so it cannot be prescribed to women during breastfeeding.

Methotrexate is contraindicated in patients with severe anemia, leukopenia, thrombocytopenia, renal or hepatic insufficiency, patients with chickenpox at the present time or inappropriately suffered from herpes zoster or other infections.

Methotrexate cannot be prescribed to patients with hypersensitivity to this drug.

Dosage and administration

Methotrexate is part of many chemotherapy regimens, and therefore, when choosing the route of administration, the regimen and dosages in each individual case, you should be guided by the data of the specialized literature.

Methotrexate for injection may be administered intramuscularly, intravenously, intraarterially or intrathecally.

The use of methotrexate in high doses can be very dangerous, so a highly conscious therapy should be carried out only by experienced chemotherapy, who can control the concentration of methotrexate in the blood plasma under stationary conditions under the cover of folinate.

During the period of treatment once a week it is necessary to investigate the blood picture.

Trophoblastic tumors: 15–30 mg intramuscularly, daily for 5 days with an interval of one or more weeks (depending on the signs of toxicity). The course of treatment is usually repeated 3 to 5 times.

Solid tumors: 30-40 mg / m2 intravenous 1 time per week.

Leukemia and lymphomas: 200-500 mg / m2 by intravenous infusion 1 time in 2-4 weeks.

Neuroleukemia: 12 mg / m2 intrathecally for 15-30 seconds 1 or 2 times a week.
When treating children, the dose is selected depending on the age of the child: children under the age of 1 year are given 6 mg, children at the age of 1 year are 8 mg, children at the age of 2 years are 10 mg, children at the age of 3 years and older are 12 mg. Before the introduction, the cerebrospinal fluid should be removed in a volume approximately equal to the volume of the lesion, which is supposed to be injected.

Highly conscious terapia: from 2 to 15 — g / m2 in the form of 4–6 hours intravenous infusion at intervals of 1–5 weeks with a mandatory subsequent administration of a folinate calcium, which is usually started 24 hours after the start of the infusion of the methotrexate and the hysterrexate, 24 hours after the start of the infusion, give metotrexate and give a set of 24 hours after the infusion; 3–40 mg / m2 (usually 15 mg / m2) and higher, depending on the concentration of methotrexate in serum for 48–72 hours (see the Instructions on the Use of Folinate Calcium).

Rheumatoid arthritis: the initial dose is usually 7.5 mg one time per week, which is administered simultaneously or divided into three doses at 12-hour intervals. In order to achieve an optimal effect, the weekly dose can be increased, while it should not exceed 20 mg. When an optimal clinical effect is achieved, a dose reduction should be initiated to achieve the lowest effective dose. The optimal duration of the terpium is unknown.

Psoriasis: therapy with methotrexate is carried out in doses of 10 to 25 mg per week. The dose is usually inflated gradually, and when the optimal clinical effect is achieved, the dose is reduced until the lowest effective dose is reached.

Mushroom mycosis: intramuscularly in 50 mg 1 time a week or 25 mg 2 times a week. Reducing the dose or cancel the introduction of the drug is determined by the reaction of the patient and hematological indices.

Side effects

Blood system: Leukopenia, neutropenia, lymphopenia (especially T-lymphocytes), thrombocytopenia, anemia.
Gastrointestinal tract and liver: Anorexia, nausea, vomiting, stomatitis, gingivitis, glossitis, enteritis, diarrhea, erosive and ulcerative diseases of the gastrointestinal tract, hepatic impairment, fibrosis and liver cirrhosis (they are likely to increase in patients, patients with hepatitis, fibrosis and liver cirrhosis or daily therapy with methotrexate).
Nervous system: Encephalopathy, especially with the introduction of multiple doses of intrathecal, and also in patients who have received radiation therapy in the region of the skull. There are also reports of fatigue, slackness, confusion, ataxia, tremor, irritability, convulsions and coma. Acute side effects caused by intrathecal administration of methotrexate may include dizziness, blurred vision, headache, pain in the back, stiffness of the back of the neck, convulsions, paralysis, hemiparesis.
Urinary system: Renal impairment is dose dependent. The risk of impairment is increased in patients with reduced renal function or dehydration, as well as in patients taking other nephrotoxic drugs. Renal insufficiency is manifested by elevated levels of creatinine and hematuria. Perhaps the appearance of cystitis.
Reproductive system: disruption of the process of oogenesis, spermatogenesis, changes in fertility, tertogenic effects.
Dermatological phenomena: Skin erythema and / or rash, krapivnitsa, alopecia (rare), photosensitivity, furunculosis, depigmentation or hyperpigmentation, acne, peeling of the skin, formation of wheals, folliculitis.
Allergic reactions: Fever, chills, rash, hay fever, anaphylaxis.
Visual organs: Conjunctivitis, excessive tearing, cataract, photophobia, cortex blindness (at high doses).
Immune status: Immunosuppression, reduced resistance to injectable diseases.
Other: Malaise, osteoporosis, hyperuricemia, vasculitis. Rarely - pneumonitis, pulmonary fibrosis.

special instructions

Methotrexate is a cytotoxic drug, so care must be taken in handling it.

Pharmaceutical forms containing preservatives, in particular benzyl alcohol, are not allowed to be used for intrathecal administration and for high-dose therapy.

With the introduction of high doses of Methotrexate, careful monitoring of the patient is necessary for early detection of the first signs of toxic reactions.

During therapy with methotrexate in high and high doses, it is necessary to monitor urine pH: on the day of administration and in the next 2–3 days, the reaction of urine should be alkaline. This is achieved by the intravenous drop-through administration of a mixture consisting of 40 ml of 4.2% sodium hydrocarbonate solution and 400–800 ml of sodium isotonic solution on the day of treatment and the next 2–3 days.

Treatment with methotrexate in high and high doses should be combined with enhanced hydration up to 2 liters of fluid per day. The administration of methotrexate at a dose of 2 g / m2 and above is carried out under the control of its concentration in blood serum. It is considered normal to decrease the content of methotrexate in serum after 22 hours after administration in; 2 times as compared with the initial level. Increasing the level of creatinine by 50% or more of the initial content and / or an increase in the level of bilirubin require intensive detoxification therapy.

For the treatment of psoriasis, Methotrexate is prescribed only to patients with a severe form of the disease that is not amenable to treatment with other types of therapy.

For toxicology profiling in the process of treatment with Methotrexate, periodic analysis of blood, determination of leukocyte and platelet counts, and liver and kidney functional tests are necessary.

In the development of diarrhea and ulcerative stomatitis, therapy with Methotrexate must be interrupted, otherwise it may lead to the development of hemorrhagic enteritis and death of the patient due to perforation of the intestine.

In patients with impaired liver function, the period for detecting Methotrexate is extended, therefore, in such patients, terrapia should be carried out with extreme caution, with the use of reduced doses.

Drug interaction

Simultaneous use of Methotrexa with various non-steroidal drugs. If special precautions are observed and appropriate monitoring is carried out, the use of methotrexate in low doses (7.5-15 mg per week), in particular in the treatment of rheumatic arthritis, is not contraindicated in the combination of anti-inflammatory drugs.

Simultaneous use of sulphoniums, derivatives

Patients receiving concomitant therapies with etretinate or other retinoids should be monitored continuously because of the increased risk of hepatotoxicity.

Multivitamin preparations containing folic acid or its derivatives can reduce the effectiveness of terpii with methotrexate.

L-asparganase is an antagonist of methotrexate.

Conducting anesthesia with the use of nitrous oxide can lead to the development of unpredictable severe myelosuppression and stomatitis.

The use of amiodarone on patients receiving terpiy with methotrexate for psoriasis may cause skin ulceration.

In several patients with psoriasis or fungal mycosis, treated with methotrexate in combination with PUVA therapy (methoxylene and ultraviolet irradiation), skin cancer was detected.

Care should be taken with the simultaneous introduction of erythrocyte mass and methotrexate.

Methotrexate is an immunosuppressant and may decrease the immunological response to vaccination if it is performed simultaneously with the therapy with methotrexate. When administered simultaneously with a live vaccine, severe antigenic reactions can occur.

Storage conditions

Keep out of reach of children at temperatures not higher than 10 ° C. Protect from light.

It is a drug. Consultation with a doctor is required.